BR55 in Prostate Cancer: an Exploratory Clinical Trial

NCT ID: NCT01253213

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.

This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BR55

Group Type: EXPERIMENTAL

BR55

Intervention Type: DRUG

One to two bolus (2nd bolus optional) of BR55 per patient

Interventions

BR55

One to two bolus (2nd bolus optional) of BR55 per patient

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male patient, age ≥ 40 years old
• Has a histology proven focal prostate cancer lesion
• The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
• Provides written Informed Consent and is willing to comply with protocol requirement

Exclusion Criteria

• Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
• Has documented acute prostatitis or urinary tract infections
• Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
• With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
• Has had severe cardiac rhythm disorders within the last 7 days
• Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
• Has received a prostate biopsy procedure within 30 days before admission into this study
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
• Is determined by the Investigator that the patient is clinically unsuitable for the study.
• Is incapable of understanding the language in which the information for the patient is given
• Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bracco Imaging S.p.A.

INDUSTRY

Sponsor Role: collaborator

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hessel Wijkstra, Dr.

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

AMC University Amsterdam

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

BR55-101

Identifier Type: -

Identifier Source: org_study_id